QC Analyst – Microbiology – Shanbally, Ringaskiddy, Cork
23 Month Contract - Onsite role Closing date: 16th August 2024
Exciting opening in QC Microbiology team at BioMarin. This role is supporting both Drug Substance and Drug Product facilities based onsite. The scope of the team includes environmental monitoring, growth promotion, water sampling and trending, biological indicator testing, bioburden, trend reporting of the control of the clean rooms onsite. Working closely with the new sterility testing team onsite and other teams onsite.
QC Microbiology is a high-performing, team-based group, where colleagues are flexible, multi-skilled and empowered to make decisions. Microbiology operates to an extremely high standard of quality and compliance.
A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
Reporting to the QC Microbiology Team Lead, this QC Microbiology analyst's role is to provide testing and SME knowledge in accordance with GMP standards.
Responsibilities Include:Microbiological testing performed by the lab including: EM; Utilities; Bioburden; Growth Promotion & BIsSupporting activities in Drug Product – including media fillsSupporting method development and validationPerform primary review of QC raw data and trend resultsDevelop, optimize, validate and troubleshoot test methodsDraft QC SOPsAct as technical resource (SME) and train other analysts in areas of expertiseEvaluate results against defined acceptance criteriaConduct and document laboratory investigations to completionMaintain the laboratory in an inspection-ready stateInteract directly with regulatory agency inspectors during auditsInterface with other BioMarin departments (Manufacturing, Quality Assurance, Engineering, etc.) and contractors as necessaryExcellent communication skills both written and verbalCustomer focus; takes personal responsibility for speed, quality and accuracy of deliverySelf-motivated and ability to work under pressureActive participation in team development and continuous improvement including standard work and 5SSuccessful track record in achieving goals as part of a team within a growing, dynamic environmentDemonstrated adaptability and flexibility to support a growing organisationReport writing on a routine basisEDUCATIONB.S. in a scientific discipline with 2+ years of relevant laboratory experience.EXPERIENCEAbility to work independently and meet established timelinesComfort with coordinating the activities with other staff membersComfort with working in a team environmentKnowledge of cGMPsExperience using quality systems such as VeevaExperience in Microbiology Lab is an advantageThis description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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